Recruiting

Breast Cancer Treatment

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT03572374

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

TEAMWork App

Information Booklet

Study Details

Brief summary:

The purpose of this study is learn more about how being treated for breast cancer affects patients' employment. Researchers are testing an early version of a mobile app designed to help breast cancer patients keep their jobs during and after treatment. The app provides advice for patients to use when having conversations about breast cancer with their employers and their doctors. The app is called TEAMWork (Talking to Employers And Medical staff about Work). In this study, the investigators are asking breast cancer patients who are about to receive treatment or who are currently receiving treatment to tell us what aspects of the app work well, so that they can learn how to improve it.

Conditions

Breast Cancer

Study ID

NCT03572374

Start date

Aug 30, 2019

Status verified date

Jun, 2026

Completion date

Oct 15, 2029

Anticipated

Primary completion date

May 31, 2026

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patient Usability Testing Inclusion Criteria:

  • History of a cancer diagnosis
  • At least 18 years of age
  • Male or Female
  • The ability to give informed consent in English or Spanish
  • Able to use and read a smartphone (iPhone or Android)
  • Has a smartphone (iPhone or Android)

Community Usability Testing Inclusion Criteria:

  • At least 18 years of age
  • Male or Female
  • The ability to give informed consent in English or Spanish
  • Able to use and read a smartphone (iPhone or Android)
  • Has a smartphone (iPhone or Android)

Focus Group and Interview Inclusion Criteria:

  • Completed chemotherapy treatment for stage I-III breast cancer.
  • Age 18 to 64 (inclusive)
  • Female
  • Paid employment (full time or part time) in the three months prior to diagnosis or at time of consent to MSK protocol #10-071 (PI: Blinder)
  • The ability to give informed consent in English or Spanish
  • Able to use and read a smartphone (iPhone or Android)
  • Has a smartphone (iPhone or Android)

For Cohort 2:

  • Participants was covered by Emergency Medicaid at the time of diagnosis and/or at any point during their treatment for breast cancer

RCT Inclusion Criteria:

  • Localized invasive breast cancer (not stage 0 or stage IV) per EMR or breast cancer (not stage 0 or stage IV) per self-report for community participants

  • If electronic medical record does not specify stage and patient is undergoing (neo)adjuvant chemotherapy, assume stage is I, II or III
  • Planning to undergo or undergoing adjuvant or neoadjuvant chemotherapy per EMR or planning to undergo or undergo chemotherapy per self-report for community participants
  • Age 18 to 64 (inclusive)
  • Female
  • Employment statue of (full time or part time) (those who are on disability leave/medical leave, and other unique employment circumstances at the PI's dicretion are eligible)
  • Language preference as English or Spanish
  • Able to use and read a smartphone or tablet (e.g. iPad, iPhone or Android)
  • Has access to a smartphone or tablet (e.g. iPad, iPhone or Android)

Exclusion Criteria:

RCT Exclusion Criteria:

  • Stage 0 breast cancer (DCIS only)
  • Stage IV (metastatic) breast cancer
  • Recurrence with metastases of breast cancer
  • Participants or family members who are participating in MSK IHCD studies related to social determinants of health

Study Design

Enrollment

546 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: TEAMWork App

The 2-pronged approach of the intervention is operationalized through 2 menus, 1 focused on interactions with the employer and the other with the clinic team. Each menu has a list of features from which participants can choose to learn about a particular topic. A "My notes" button allows participants to take notes directly on the app. These notes will not be available to the research team, such that participants may use the tool without concerns about privacy. The workplace accommodations menu includes sample videos using trained actors to demonstrate how to approach an employer to request accommodations. Additional features include suggestions for accommodations that may be helpful, templates for letters participants can use when requesting accommodations, links to relevant websites, information about legal protections, and contact information for lawyers and firms that provide pro bono assistance.

active comparator: Information Booklet (control)

Participants will receive a booklet that includes the information in the app that can practicably be converted to paper. These participants will not have access to the multimedia aspects of the intervention, such as the videos, but they will have all of the relevant information in the app described above, including suggestions for accommodations, written templates for letters, links to websites, information about legal protections, and contact information for pro bono legal assistance. The booklet will also contain information about chemotherapy, radiation therapy and surgery, recommendations for management of common symptoms, and advice for communicating with the clinic team. The information booklet will be provided entirely on paper, although participants may independently access websites recommended in the booklet. The booklet content will mirror the app with regard to cultural responsiveness and appropriateness for different job types and characteristics.

Interventions

TEAMWork App

The 2-pronged approach of the intervention is operationalized through 2 menus, 1 focused on interactions with the employer and the other with the clinic team. Each menu has a list of features from which participants can choose to learn about a particular topic. A "My notes" button allows participants to take notes directly on the app. These notes will not be available to the research team, such that participants may use the tool without concerns about privacy. The workplace accommodations menu includes sample videos using trained actors to demonstrate how to approach an employer to request accommodations. Additional features include suggestions for accommodations that may be helpful, templates for letters participants can use when requesting accommodations, links to relevant websites, information about legal protections, and contact information for lawyers and firms that provide pro bono assistance.

Information Booklet

Participants in the control arm will receive a booklet that includes the information in the app that can practicably be converted to paper. These participants will not have access to the multimedia aspects of the intervention, such as the videos, but they will have all of the relevant information in the app described above, including suggestions for accommodations, written templates for letters, links to websites, information about legal protections, and contact information for pro bono legal assistance. The booklet will also contain information about chemotherapy, radiation therapy and surgery, recommendations for management of common symptoms, and advice for communicating with the clinic team. The information booklet will be provided entirely on paper, although participants may independently access websites recommended in the booklet. The booklet content will mirror the app with regard to cultural responsiveness and appropriateness for different job types and characteristics.

Primary outcome measure

  • number of participants still employed [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Victoria Blinder, M.D., M.Sc.

646-888-4808blinderv@mskcc.org

Francesca Gany, M.D., M.Sc.

646-888-8054

Locations

Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Victoria Blinder, M.D., M.Sc

646-888-4808

Memorial Sloan Kettering Monmouth (Consent and Follow-up)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Victoria Blinder, MD, MSc

646-888-4808

Memorial Sloan Kettering Bergen (Consent and Follow up)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Victoria Blinder, M.D., M.Sc.

646-888-4808

Memorial Sloan Kettering Westchester (Consent and Follow-up)

Recruiting

Harrison, New York, United States, 10604

Contacts

Victoria Blinder, M.D., M.Sc

646-888-4808

Queens Cancer Center of Queens Hospital

Recruiting

Jamaica, New York, United States, 11432

Contacts

Margaret Kemeny, MD

718-883-4031

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Victoria Blinder, M.D., M.Sc

646-888-4808

Francesca Gany, M.D., M.Sc

646-888-8054

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Della Makower, MD

718-862-8840

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Workforce
  • Employers
  • Talking to Employers and Medical Staff About Work (TEAMWork)
  • 18-217

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-12.